FDA-Device2021-04-14Class II
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
Clerio Vision
Hazard
Contact lenses may be mislabeled with the incorrect lens power.
Sold states
Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.
Affected count
153 lenses
Manufactured in
7575 Commerce Ct, N/A, Sarasota, FL, United States
Products
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1352-2021Don't want to check this manually?
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